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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Incontinence (1928); Injury (2348); Blood Loss (2597)
Event Date 04/29/2011
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿device is unable to be retrieved, bleeding, incontinence, shortness of breath". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. Unknown if the reported bleeding, incontinence, and shortness of breath is directly related to the filter and unable to identify a corresponding failure mode at this point in time no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
 
Manufacturer Narrative
(b)(4). Lot#: unknown. Catalog#: unknown but refered to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. Mfr date unknown as lot# is unknown. Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2011 at (b)(6) healthcare. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 08/15/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2011 via the right jugular vein due to dvt and pe. Plaintiff is alleging device is unable to be retrieved, bleeding, incontinence, and intermittent shortness of breath. Patient alleges attempted retrieval on (b)(6) 2011.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key5793280
MDR Text Key249345087
Report Number3002808486-2016-00714
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 09/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/06/2016
Event Location No Information
Date Manufacturer Received09/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/14/2016 Patient Sequence Number: 1
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